Colorectal Liver MetastasesNCT03888638
The Role of Tumor-associated Macrophages in Colorectal Liver Metastases
An observational study of Colorectal Liver Metastases and Colorectal Cancer, run by Humanitas Clinical and Research Center.
Trial summary
Colorectal cancer is a major cause of mortality worldwide. Most patients develop colorectal liver metastases (CLM), and for such patients hepatectomy combined with chemotherapy may be curative. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Liver Metastases, Colorectal Cancer, Liver Metastases
- What is being tested?
- Hepatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 101 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients affected by colorectal liver metastases treated by hepatectomy.
Who may be able to join
- Patients with colorectal liver metastases undergoing hepatectomy
- Full clinical, surgical, pathological and follow-up data
- Availability of tissues for the analysis
Who cannot join
- Missing (any) data
- Combination of radiofrequency or microwave ablation plus surgery
About this study
Official title: Search for the Clinical Significance of Tumor-associated Macrophages in Patients With Colorectal Liver Metastases
Colorectal cancer is a major cause of mortality worldwide. Most patients develop colorectal liver metastases (CLM), and for such patients hepatectomy combined with chemotherapy may be curative. Nevertheless, in the era of precision medicine there is a critical need of prognostic markers to cope with the heterogeneity of CLM patients. Tumor-associated macrophages (TAMs) pave the way to tissue invasion and intravasation providing a nurturing microenvironment formetastases. The quantification of immune landscape of tumors has provided novel prognostic indicators of cancer progression, and the quantification of TAMs might explain the heterogeneity of CLM patients. Here, we will investigate the development of a new diagnostic tool based on TAMs with the aim to define the causative role of TAMs in CLM patients. This will open new clinical scenarios both for the diagnosis, therapy and prognosis, leading to the refinement of the therapeutic output in a personalized medicine perspective.
Read the detailed description
Some preliminary data produced by the research team from Humanitas Clinical and Research Center in Milan (ITALY) have shown that TAMs in CLM are heterogeneous and that their diversity can be distinguished based on their morphology and functionality. Therefore, TAMs may represent an additional tool in the definition of the biology and prognosis of CLM patients. This preliminary finding provides us with the rationale to undertake a prospective study on a large series of CLM patients surgically resected by our unit aimed at validating the promisingcorrelation between different TAMs phenotypes and patients prognosis. The characterization of the diversity of TAMs in CLM will be refined using state of the art technology, including multi-parametric flow cytometry, single cell RNA sequencing (scRNA-seq) transcriptional profiling, metabolomic, and proteomic analyses. The expected findings will allow us to develop a new diagnostic tool based on TAMs features, which will open the way to new criteria for patient stratification and for the design of new targeted therapies in a personalized medicine perspective.
- Being tested
- Hepatectomy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HepatectomyProcedure or surgery
Also called Liver resection
Removal of a part of the liver because of tumor
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Analysis of survival after hepatic resection for colorectal liver metastases according with the tumor-associated macrophages characteristics
Measured: From date of surgery until the date of first documented progression or date of death from any cause, which ever came first assessed up to 72 months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start1 Jan 2015
- Primary completion31 Dec 2017
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal Liver MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humanitas Clinical and Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matteo Donadon, Humanitas Clinical and Research Center
- Investigators
- Matteo Donadon, MD, PhD, Principal investigator, Humanitas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03888638
- Sponsor's protocol ID
- TAMs in CLM
- Status last verified
- Mar 2019
- First submitted
- 21 Mar 2019
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Costa G, Sposito C, Soldani C, Polidoro MA, Franceschini B, Marchesi F, Nasir FD, Virdis M, Vingiani A, Leo A, Di Tommaso L, Kotha S, Mantovani A, Mazzaferro V, Donadon M, Torzilli G. Macrophage morphology and distribution are strong predictors of prognosis in resected colorectal liver metastases: results from an external retrospective observational study. Int J Surg. 2023 May 1;109(5):1311-1317. doi: 10.1097/JS9.0000000000000374.
PubMed 37037585
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Search for the Clinical Significance of Tumor-associated Macrophages in Patients With Colorectal Liver Metastases
- ClinicalTrials.gov ID
- NCT03888638
- Acronym / sponsor ID
- TAMs in CLM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Humanitas Clinical and Research CenterUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 25 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Colorectal cancer is a major cause of mortality worldwide. Most patients develop colorectal liver metastases (CLM), and for such patients hepatectomy combined with chemotherapy may be curative. Nevertheless, in the era of precision medicine there is a critical need of prognostic markers to cope with the heterogeneity of CLM patients. Tumor-associated macrophages (TAMs) pave the way to tissue invasion and intravasation providing a nurturing microenvironment formetastases. The quantification of immune landscape of tumors has provided novel prognostic indicators of cancer progression, and the quantification of TAMs might explain the heterogeneity of CLM patients. Here, we will investigate the development of a new diagnostic tool based on TAMs with the aim to define the causative role of TAMs in CLM patients. This will open new clinical scenarios both for the diagnosis, therapy and prognosis, leading to the refinement of the therapeutic output in a personalized medicine perspective.
Detailed description
Some preliminary data produced by the research team from Humanitas Clinical and Research Center in Milan (ITALY) have shown that TAMs in CLM are heterogeneous and that their diversity can be distinguished based on their morphology and functionality. Therefore, TAMs may represent an additional tool in the definition of the biology and prognosis of CLM patients. This preliminary finding provides us with the rationale to undertake a prospective study on a large series of CLM patients surgically resected by our unit aimed at validating the promisingcorrelation between different TAMs phenotypes and patients prognosis. The characterization of the diversity of TAMs in CLM will be refined using state of the art technology, including multi-parametric flow cytometry, single cell RNA sequencing (scRNA-seq) transcriptional profiling, metabolomic, and proteomic analyses. The expected findings will allow us to develop a new diagnostic tool based on TAMs features, which will open the way to new criteria for patient stratification and for the design of new targeted therapies in a personalized medicine perspective.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by colorectal liver metastases treated by hepatectomy.
Key inclusion criteria (3 listed)
- Patients with colorectal liver metastases undergoing hepatectomy
- Full clinical, surgical, pathological and follow-up data
- Availability of tissues for the analysis
Key exclusion criteria (2 listed)
- Missing (any) data
- Combination of radiofrequency or microwave ablation plus surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HepatectomyAlso: Liver resectionRemoval of a part of the liver because of tumor | Procedure or surgery | – |
Primary outcome
Survival
Time frame: From date of surgery until the date of first documented progression or date of death from any cause, which ever came first assessed up to 72 months]
Analysis of survival after hepatic resection for colorectal liver metastases according with the tumor-associated macrophages characteristics
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
- Derived from this study: PubMed 37037585Costa G, Sposito C, Soldani C, Polidoro MA, Franceschini B, Marchesi F, Nasir FD, Virdis M, Vingiani A, Leo A, Di Tommaso L, Kotha S, Mantovani A, Mazzaferro V, Donadon M, Torzilli G. Macrophage morphology and distribution are strong predictors of prognosis in resected colorectal liver metastases: results from an external retrospective observational study. Int J Surg. 2023 May 1;109(5):1311-1317. doi: 10.1097/JS9.0000000000000374.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matteo Donadon, MD, PhD principal investigator
Humanitas University
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Liver Metastases and Colorectal Cancer, run by Humanitas Clinical and Research Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: From date of surgery until the date of first documented progression or date of death from any cause, which ever came first assessed up to 72 months]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03888638, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2019.